A Study to Evaluate Injection Pain and Local Tolerability Following Subcutaneous (SC) Administration of TV-46046

NCT03700658 | Completed Phase 1 Results FDA Drug

• 1 other identifier: TV46046-WH-10147
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the local tolerability associated with the SC administration of TV-46046, and inform next steps of the TV-46046 development program.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Injection Site Reactions (ISRs) (Excluding Injection Site Pain)

  ISRs were assessed by self-reports and direct observation for each injection at least twice on the day of injection. ISRs included erythema (redness), swelling, pruritus (itching), bleeding, bruising, injection site discoloration (for example, hypopigmentation), or atrophy (that is, dimple).

  Day 0 (immediately after and 1 hour after the injection) up to Month 18

Secondary Outcomes (3)

• Injection Site Pain Score, as Assessed by Numerical Rating Scale (NRS)

  Day 0 (Immediately after and 1 hour after injection)

• Participant's Perception of Pain, as Assessed by an Overall Ranking of the 4 Study Injections From Least to Most Painful

  Day 0 (1 hour after injection)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  Day 0 up to Month 18

Study Arms (4)

TV-46046 Undiluted

EXPERIMENTAL

Participants will receive TV-46046 undiluted (120 mg/0.3 mL of 400 mg/mL) SC injection as a test formulation in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart.

Drug: TV-46046

TV-46046 Diluted

EXPERIMENTAL

Participants will receive TV-46046 saline-diluted (60 mg/0.3 mL of 200 mg/mL) SC injection as a test formulation in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart.

Drug: TV-46046

TV-46046 Placebo

PLACEBO COMPARATOR

Participants will receive TV-46046 placebo (0.3 mL) SC injection in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart.

Drug: TV-46046 Placebo

Depo-subQ 104

ACTIVE COMPARATOR

Participants will receive Depo-subQ 104 (medroxyprogesterone acetate injectable suspension; 104 mg/0.65 mL) SC injection as a reference formulation in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart.

Drug: Depo-subQ 104

Interventions

TV-46046 DRUG

TV-46046 will be administered per dose and schedule specified in the arm.

TV-46046 Diluted; TV-46046 Undiluted

Depo-subQ 104 DRUG

Depo-subQ 104 will be administered per dose and schedule specified in the arm.

Also known as: Medroxyprogesterone acetate injectable suspension, Depo-subQ Provera 104®

Depo-subQ 104

TV-46046 Placebo DRUG

TV-46046 Placebo will be administered per schedule specified in the arm.

TV-46046 Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant has a low risk of pregnancy (that is, sterilized, in exclusively same-sex partnership, in menopause and/or post-menopausal, abstinent, in a monogamous relationship with vasectomized partner, using nonhormonal intrauterine device \[IUD\], or consistent use of condoms)
• Participant is not pregnant and does not have desire to become pregnant in the subsequent 18 months
• Participant had a normal mammogram within the last year, if 40 years or older
• Participant has no skin disorders or skin allergies
• Additional criteria apply, please contact the investigator for more information

You may not qualify if:

• Participant has hypertension
• Participant has ischemic heart disease or a history of ischemic heart disease
• Participant has a history of stroke
• Participant has a history of thromboembolic event(s)
• Participant has systemic lupus erythematosus
• Participant has rheumatoid arthritis and is undergoing immunosuppressive therapy
• Participant has migraine with aura
• Participant has unexplained vaginal bleeding
• Participant has diabetes
• Participant has a strong family history of breast cancer
• Participant has cervical cancer or a history of cervical cancer
• Participant has severe cirrhosis (decompensated) or liver tumors
• Participant has known significant renal disease
• Participant has a history of diagnosed clinical depression or bipolar disorder, with or without suicidal ideation, and/or history of suicide attempt
• Participant is currently using hormonal contraception

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead
• FHI 360: collaborator

Study Sites (1)

Teva Investigational Site 1

Santo Domingo, Dominican Republic

Location

MeSH Terms

Interventions

Medroxyprogesterone Acetate

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products R&D, Inc.

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study will be partially blinded due to differences in appearance and volume of the treatments. Designated unblinded study staff will conduct randomization procedures. The staff preparing and administering injections will also be unblinded to treatment sequence but will be trained to shield the syringe prior to and at the time of injection from view of the participant and study staff assessing injection site reactions (ISRs).
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 9, 2018
• Study Start: January 15, 2019
• Primary Completion: October 2, 2020
• Study Completion: October 2, 2020
• Last Updated: January 26, 2022
• Results First Posted: January 26, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share

Locations

DO (1)